Manager-Clinical Trials and R and D
Chemidrug Industries Pvt. Ltd.
Highly motivated oncology and hematology scientist with >10 years of research experience in oncology and drug Cardio toxicity. • Experienced in systemic literature review, interpretation, and summarization of preclinical and clinical data. • Experienced in writing accurate manuscripts for scientific journals, book chapters, research grants, protocols, SOPs, and study reports. • Experienced in managing research collaboration with key opinion leaders, in deciphering complex scientific information, in presenting different clinical and pre-clinical research findings to a wide range of audiences, including scientists, clinicians, and non-clinicians. • Foreign pharmacist with comprehensive knowledge of physiology, disease state, pharmacy, pharmacology, biochemistry, toxicology, pharmacotherapeutics, clinical trials, and medical devices trials. • Supervised and supported R&D team involved in IVD/LDT/RUO assay validations in compliance with FDA/EMA/ CLIA/ICH regulatory agencies, regulatory affairs, quality assurance, and quality control focused on client companies. • Experienced in preparing client-specific clinical study validation protocols, medical device validation, reports and amendments, SOPs, SAPs, study reports, and regulatory documents for FDA PMA submissions. • Robust peer-review publication record, and worked as independent scientific reviewer. • Worked closely with the clinical R&D team to provide leadership and direction to pharmaceutical manufacturing team, supervised and trained research students. • Excel at timely coordination and management of multiple complex projects. • Self-motivated and resourceful, with excellent interpersonal skills; composed personality with the ability to adapt to new environments and communicate efficiently. • Proficient with Microsoft office, reference manager, endnote, prism, adobe photoshop.